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IRCT20220520054927N1 IRCT 2022-09-08 Shiraz University of Medical Sciences The effect of Tranexamic acid administration on non-traumatic Intracerebral hemorrhage in contrast with placebo The effect of Tranexamic acid administration on non-traumatic Intracerebral hemorrhage in contrast with placebo in Namazi hospital. 2022-07-23 anticipated 100 Complete https://irct.ir/trial/63826 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, eligible patients will be randomized as case and control groups. in the case group, they will receive Tranexamic acid and in the control group, they will receive a placebo. To allocate participants in case and control groups, permuted block randomization will be used. based on the sample size (100 patients), 10 blocks that contain 10 numbers will be created. We use Random allocation software to perform randomization, Blinding description: In this study, participants in both groups will be blinded to drug or placebo administration via injection of the same amount with the same physical properties of drug or placebo. 3 Intraparanchymal hemorrhage. Intervention 1: Intervention group: After admission in hospital and diagnosis of intra paranchimal hemorrhage with radiologic evaluations, patients will receive Injection of 1gr tranexamic acid intravenously in 100cc normal salin 0.9% within 10 minutes, then 1gr tranexamic acid in 50cc normal salin 0.9% within 8 hours. Also, all patients in intervention group will be treated with necessary routine drugs such as anticonvusive and antihypertension drugs. Intervention 2: Control group: Control group: In this group receive the same anticonvulsive and antihypertension drugs, also same amount of normal salin 0.9% but distilled water will be injected instead of tranexamic acid as a placebo. Yes - There is a plan to make this available What will be shared: Full text of original article Data file When: starting 6 months after publication To whom: available for people working in academic institutions and who works in businesses Conditions: Any analytic tests with authors permission is possible. Where to obtain: Via Email or telephone numbers How to obtain: Requaired data will be sent to Email Comments:
public Mohammad Jamali
Zand street
Shiraz Iran (Islamic Republic of) 7193613565 +98 71 3647 3882 mohammad.jamali.ns@gmail.com Shiraz University of Medical Sciences scientific Mohammad Jamali
Zand street
Shiraz Iran (Islamic Republic of) 7193613565 +98 71 3647 3882 mohammad.jamali.ns@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 18-75 years old Acute non-traumatic intra-paranchimal hemorrhage Less than 12 hours since bleeding 18 years 75 years Both Multiple intra-paranchimal hemorrhage Contraindication for Anti-phybrinolytic treatment Massive ntra-paranchimal hemorrhage (>70cc) Stem ICH cerebral aneurysm or vascular anomalies Post CVA hemorrhagic formation Cerebral venous thrombosis Anti-thrombolytic therapy Brain tumor or infection I61.0 Nontraumatic intracerebral hemorrhage in hemisphere, subcortical Treatment - Drugs Placebo Intervention group: After admission in hospital and diagnosis of intra paranchimal hemorrhage with radiologic evaluations, patients will receive Injection of 1gr tranexamic acid intravenously in 100cc normal salin 0.9% within 10 minutes, then 1gr tranexamic acid in 50cc normal salin 0.9% within 8 hours. Also, all patients in intervention group will be treated with necessary routine drugs such as anticonvusive and antihypertension drugs. Control group: Control group: In this group receive the same anticonvulsive and antihypertension drugs, also same amount of normal salin 0.9% but distilled water will be injected instead of tranexamic acid as a placebo Expansion of intraparanchymal hemorrhage. Timepoint: Before intervention, 1 and 3 days later. Method of measurement: Brain CT scan. Shiraz Medical University of Science Approved 2021-12-27 Research ethic committees of school of medicine, Shiraz university of medical sciences. Zand street, namazi hospital Shiraz Fars Iran (Islamic Republic of)